HEATING PAD W30402EA 832

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-01 for HEATING PAD W30402EA 832 manufactured by Sunbeam.

Event Text Entries

[84934282] The submitter's husband plugged the heating pad to the wall and turned it on to a medium / low heating level. He then placed the heating pad on his back. Approx 5 minutes later, the submitter's husband noticed the heating pad was very hot and when he took it off his back he noticed it was smoking. The submitter's husband unplugged the heating pad and threw it outside of his home. The submitter indicated that the heating pad stopped smoking after a few minutes but it remained hot for a few hours. The submitter indicated that the heating pad has burn holes in the top, in the middle and on the right side. She also said the wires are all black and she has pictures of the damages. The submitter emailed the firm and informed them about the incident (case #(b)(4). ) she received a response yesterday, asking her to contact them via phone and provide the numbers found on the prongs. The submitter plans to call the firm. Document number: (b)(4). Report number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5071905
• MDR Report Key: 6838745
• Date Received: 2017-09-01
• Date of Report: 2017-08-31
• Date of Event: 2017-08-05
• Date Added to Maude: 2017-09-01
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: HEATING PAD
• Generic Name: HEATING PAD
• Product Code: ILY
• Date Received: 2017-09-01
• Model Number: W30402EA 832
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SUNBEAM

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-09-01